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Clinical Trials/NCT01576562
NCT01576562
Completed
N/A

Implantable Cardioverter Defibrillator (ICD) Function During Ventricular Assist Device (VAD) Implantation

Virginia Commonwealth University1 site in 1 country37 target enrollmentFebruary 2014
ConditionsHeart Failure

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Virginia Commonwealth University
Enrollment
37
Locations
1
Primary Endpoint
observational study to assess potential changes that may occur in the RV ICD lead function during LVAD implantation and what mechanism may cause those changes in RV ICD lead function
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this research study is to test the function of a subjects implantable cardioverter defibrillator (ICD) function throughout the duration of their heart surgery. ICD function can be altered during some types of heart surgery such as those when a pump (ventricular assist device - VAD) is implanted. The investigators would like to study the mechanism of device and ICD malfunction.

Detailed Description

ICD function is typically measured prior to and after surgery. For the study, the investigators will measure ICD lead function multiple times throughout the surgery as well, to determine if and when device malfunction occurs. ICD lead function is measured noninvasively through a specialized computer the same way it is checked in the clinic. In addition, the investigators will test ICD function as they usually do following surgery.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
May 2016
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients ages 18 and older
  • Have a wireless implantable cardioverter defibrillator (ICD) and are undergoing VAD implantation or other cardiothoracic surgery.

Exclusion Criteria

  • Patients who are pacemaker dependent
  • children, human fetuses, neonates
  • prisoners will not be included
  • Pregnant women will not be included

Outcomes

Primary Outcomes

observational study to assess potential changes that may occur in the RV ICD lead function during LVAD implantation and what mechanism may cause those changes in RV ICD lead function

Time Frame: RV ICD lead function will be measured throughout LVAD placement , at 1 week post LVAD placement, and 3 months post LVAD placement Description:

Study Sites (1)

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